Twin Block, Pain Medications and Third Molar Extractions

ConditionAcute Pain
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorRutgers, The State University of New Jersey

About this trial

Each year, over 3.5 million, mostly, healthy young adults, have their third molar teeth ('wisdom teeth') removed under sedation and are often given opioid prescriptions for managing their pain. Wisdom molar removal is one of the most common reasons for opioid prescriptions to be given to adolescents. There is a national thrust to reduce both the dose and the duration of such opioid prescriptions because even short-term opioid exposures increase risk for narcotic addiction and misuse. Non-opioid options to manage pain will still allow for sufficient pain control without risking addiction, and hence, a fundamental component of our response to combat the current national opioid crisis.

The investigators are going to study a promising option- the Twin Block dental anesthetic injection. The Twin block involves injecting the standard dental numbing medication in a way that 'numbs' the 'jaw-clencher' muscles on the side of the face. The investigators found that the Twin block relieved jaw pain stemming from these muscles, in a quick and sustained manner, even in patients whose pain following wisdom tooth removal primarily came from 'taut' and tender jaw-clencher muscles. However, what is not known is- how often do patients who have their wisdom teeth removed under sedation, end up in significant pain from taut and tender jaw-clencher muscles? Will using the twin block effectively reduce pain in such patients? In this pilot study, the investigators will examine wisdom molar extraction patients one day after their procedure. Those with significant pain (pain rated ≥ 5 on a 0-10 scale) in their jaw-clencher muscles, will get either the Twin block injection or a placebo. The investigators will track both 1) pain before and after the injection, and 2) pain medication usage over a 7-day period to see if both pain and opioid dosage come down with the Twin block. This study can support a simple, safe and inexpensive means to reduce pain after a common procedure.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

All patients requiring extraction/s of at least 1 lower wisdom (third) molar that is partially/fully 'impacted', under intravenous sedation, are eligible to participate in this study so long as they

are older than 18 years of age,

are healthy,

have no cognitive/intellectual disability,

Disqualifiers

Compromised ability to guard their self-interest, for e.g., prisoners, children, pregnant women, patients with intellectual/cognitive disability are not enrolled in the study.

Those patients who present with infection/inflammation involving the third molars slated for extractions, on the day of their procedure, may not take part in the study.

In addition, those who have had opioid pain medication/s in the past to address short-term or long-standing pain, or those who are on long term prescription of anti-inflammatory pain medication, are unable to participate.

Those with long standing pain of the jaw joint or muscles.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Twin block local anesthetic nerve block using standard dental anesthetic

    Drug

    2% lidocaine with 1:100,000 epinephrine is the standard dental local anesthetic in universal use. This drug will be administered as the Twin block local anesthetic nerve block targeting the branches of the mandibular nerve supplying the temporalis and masseter muscles.

  • Twin block with placebo

    Other intervention

    Instead of the standard dental anesthetic, sterile normal saline will be delivered using the Twin block injection

Treatment groups

48 Participants
are divided into 2 treatment groups
Group A: Twin Block with Local AnestheticActive comparator 1 intervention
Group B: Twin Block with sterile normal salinePlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Post-injection muscle pain

NRS pain scores before and 15 min after Twin block administration on day after procedure

Time frame
15 minutes
2

Mean NRS pain score

Means NRS pain score by Day, comparing placebo and Twin block groups

Time frame
one week
3

Total prescription opioid consumption

Comparison of total prescription opioid consumption (mg) between placebo and Twin block groups

Time frame
one week

Secondary outcomes

1

Passive mouth opening

Comparison of passive mouth opening before and 15 min after Twin block administration on day after procedure

Time frame
15 min
2

Passive mouth opening

Comparison of baseline and end-of-study passive mouth opening between Twin block and placebo groups

Time frame
one week

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Rutgers, The State University of New Jersey

Lead sponsor

New Jersey Health Foundation

Collaborator